BEUDAMED
    FDA Recall Open, Classified

    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

    Recall: Z-1467-2022 · Initiated June 7, 2022

    Recall

    Recall Number
    Z-1467-2022
    Event Number
    90519
    Firm
    Covidien Llc
    FEI Number
    1282497
    Product Code
    HIH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 7, 2022
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

    Reason

    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

    Action

    Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: "Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility. " Return all affected product in your inventory to Medtronic. a. Product purchased directly from Medtronic: [email protected] b. Product purchased through distributor: [email protected] " Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Complete the enclosed Customer Confirmation Form and email it to [email protected] " If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.

    Distribution

    AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain

    Quantity

    33 units